July 14, 2008 Approval Letter (2) - Fluzone

We have approved your request to supplement your Biologics License Application for Influenza Virus Vaccine, to include the 2008-2009 United States formulation.

Please submit all final printed labeling at the time of use and include implementation information on FDA form 356h. Please provide PDF-format electronic copies of these labels. We will include the information contained in the above referenced supplement in your Biologics License Application file.

Sincerely yours,

--signature--

Loris D. McVittie, Ph.D.
Acting Director
Division of Vaccines and Related Products Applications
Office of Vaccines Research and Review
Center for Biologics Evaluation and Research